Phase II Clinical Experience With the Novel Proteasome Inhibitor Bortezomib in Patients With Indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma

2005 ◽  
Vol 23 (4) ◽  
pp. 676-684 ◽  
Author(s):  
Owen A. O'Connor ◽  
John Wright ◽  
Craig Moskowitz ◽  
Jamie Muzzy ◽  
Barbara MacGregor-Cortelli ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Proteasome Inhibitor ◽  
Hodgkin’S Lymphoma ◽  
Marginal Zone ◽  
Cell Lymphoma ◽  
Marginal Zone Lymphoma ◽  
Hodgkin's Lymphoma ◽  
The Novel ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell

Purpose To determine the antitumor activity of the novel proteasome inhibitor bortezomib in patients with indolent and mantle-cell lymphoma (MCL). Patients and Methods Patients with indolent and MCL were eligible. Bortezomib was given at a dose of 1.5 mg/m2 on days 1, 4, 8, and 11. Patients were required to have received no more than three prior chemotherapy regimens, with at least 1 month since the prior treatment, 3 months from prior rituximab, and 7 days from prior corticosteroids; absolute neutrophil count more than 1,500/μL (500/μL if documented bone marrow involvement); and platelet count more than 50,000/μL. Results Twenty-six patients were registered, of whom 24 were assessable. Ten patients had follicular lymphoma, 11 had MCL, three had small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL), and two had marginal zone lymphoma. The overall response rate was 58%, with one complete remission (CR), one unconfirmed CR (CRu), and four partial remissions (PR) among patients with follicular non-Hodgkin's lymphoma (NHL). All responses were durable, lasting from 3 to 24+ months. One patient with MCL achieved a CRu, four achieved a PR, and four had stable disease. One patient with MCL maintained his remission for 19 months. Both patients with marginal zone lymphoma achieved PR lasting 8+ and 11+ months, respectively. Patients with SLL or CLL have yet to respond. Overall, the drug was well tolerated, with only one grade 4 toxicity (hyponatremia). The most common grade 3 toxicities were lymphopenia (n = 14) and thrombocytopenia (n = 7). Conclusion These data suggest that bortezomib was well tolerated and has significant single-agent activity in patients with certain subtypes of NHL.

Weekly Treatment with a Combination of Bendamustine and Bortezomib in Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma: A Single- Center Phase 1/2 Study.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1574-1574 ◽  
Author(s):  
Peter R Moosmann ◽  
Marc Heizmann ◽  
Nina Kotrubczik ◽  
Mario Bargetzi ◽  
Martin Wernli
Keyword(s):  
Adverse Events ◽  
Follicular Lymphoma ◽  
Mantle Cell Lymphoma ◽  
Hodgkin’S Lymphoma ◽  
Cell Lymphoma ◽  
Phase 1 ◽  
Hodgkin's Lymphoma ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell

Abstract Besides its established role in the treatment of patients with multiple myeloma, the proteasome inhibitor bortezomib is active in patients with a variety of indolent non-Hodgkin’s lymphomas, notably mantle cell lymphoma and follicular lymphoma. Bendamustine was originally designed as a bifunctional anticancer compound combining an alkylating and an antimetabolite function. It has strong efficacy in non-Hodgkin’s lymphoma and multiple myeloma, and apparently low cross-resistance with other alkylating agents. This open label, single-center phase 1/2 study evaluated a weekly combination of bortezomib and bendamustine in patients with relapsed or refractory indolent non-Hodgkin’s lymphoma. The primary endpoint was to define the maximal tolerated dose (MTD). Secondary endpoints were tolerability and response. On days 1, 8, 15, and 22 of a 35-day cycle, patients received intravenous bolus bortezomib 1.6 mg/m2 for a maximum of 3 cycles. Bendamustine was administered as 30-min. intravenous infusion on days 1, 8, and 15. Dose escalation was started at a dose of 60 mg/m2 bendamustine. Response was assessed at the end of study treatment. Four patients entering the first dose level showed no dose-limiting toxicity (DLT). Thereupon, bendamustine dosage was increased to 80 mg/m2. In 3 out of 5 patients, DLT was observed. Dose-limiting adverse events were grade 3 diarrhea with dehydration, fatigue, and grade 4 thrombocytopenia, respectively. Adverse events with an overall incidence of ≥20% were diarrhea, nausea, vomiting, thrombocytopenia, and fatigue. There were no infectious or dose-limiting neurological adverse events. The 9 patients (7 females) in the phase 1 part of this trial, 5 with relapsed, 4 with refractory stage III (n=2) or stage IV (n=7) disease, received a median of 2 treatment cycles (range 2–3). Median age was 71 yrs (range 55–85). Detailed histological diagnoses were mantle cell lymphoma (n=4), follicular lymphoma (n=4), and Waldenstroem’s macroglobulinemia (n=1). All patients were pretreated (median 3 lines of treatment, range 2–8). Prior treatments comprised rituximab (n=7), anthracyclines (n=4), ibritumomab tiuxetan (n=2), bortezomib (n=2), and autologous stem cell transplantation (n=1). The reasons for not completing the planned 3 treatment cycles were DLT (n=2), and disease progression (n=3). As best response, partial remission was achieved in 6 patients, while disease progressed in 3 patients. Among the different types of lymphoma, partial remissions were observed in all 4 mantle cell lymphoma patients, 1 out of 4 follicular lymphoma patients, and in the Waldenstroem’s macroglobulinemia patient. The trial’s phase 2 part is currently ongoing. In conclusion, weekly bortezomib and bendamustine (1.6 mg/m2 d1, 8, 15, & 22 and 60 mg/m2 d1, 8, & 15 q5w, respectively) was found to have acceptable toxicity. Moreover, this study demonstrates initial evidence of efficacy of the combination in heavily pretreated patients with indolent non-Hodgkin’s lymphoma, particularly mantle cell lymphoma.

Phase II Multicenter Study of Bendamustine Plus Rituximab in Patients With Relapsed Indolent B-Cell and Mantle Cell Non-Hodgkin's Lymphoma

2008 ◽  
Vol 26 (27) ◽  
pp. 4473-4479 ◽  
Author(s):  
K. Sue Robinson ◽  
Michael E. Williams ◽  
Richard H. van der Jagt ◽  
Philip Cohen ◽  
Jordan A. Herst ◽  
...  
Keyword(s):  
B Cell ◽  
Mantle Cell Lymphoma ◽  
Hodgkin’S Lymphoma ◽  
Cell Lymphoma ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell ◽  
Grade 3

PurposeBendamustine HCl is a bifunctional mechlorethamine derivative with clinical activity in the treatment of non-Hodgkin's lymphoma. This study evaluated bendamustine plus rituximab in 67 adults with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab.Patients and MethodsPatients received rituximab 375 mg/m2intravenously on day 1 and bendamustine 90 mg/m2intravenously on days 2 and 3 of each 28-day cycle for four to six cycles. An additional dose of rituximab was administered 1 week before the first cycle and 4 weeks after the last cycle. Sixty-six patients (median age, 60 years) received at least one dose of both drugs.ResultsOverall response rate was 92% (41% complete response, 14% unconfirmed complete response, and 38% partial response). Median duration of response was 21 months (95% CI, 18 to 24 months). Median progression-free survival time was 23 months (95% CI, 20 to 26 months). Outcomes were similar for patients with indolent or mantle cell histologies. The combination was generally well tolerated; the primary toxicity was myelosuppression (grade 3 or 4 neutropenia, 36%; grade 3 or 4 thrombocytopenia, 9%).ConclusionBendamustine plus rituximab is an active combination in patients with relapsed indolent and mantle cell lymphoma.

scholarly journals Development of a clinically relevant chemoresistant mantle cell lymphoma cell culture model

2019 ◽  
Vol 244 (11) ◽  
pp. 865-872
Author(s):  
Jia He ◽  
Khalid A Hajj ◽  
Christopher M Knapp ◽  
Kathryn A Whitehead
Keyword(s):  
Mantle Cell Lymphoma ◽  
Hodgkin’S Lymphoma ◽  
Cell Lymphoma ◽  
In Vitro Models ◽  
Hodgkin's Lymphoma ◽  
Selection Strategy ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell

Mantle cell lymphoma is an aggressive subtype of non-Hodgkin’s lymphoma that claims the lives of tens of thousands of people every year. Although combination chemotherapy treatments such as CHOP have yielded promising outcomes in the clinic, the development of chemoresistance in patients has limited their long-term success. The lack of in vitro chemoresistance models has limited our ability to understand the mechanisms by which cells develop resistance, and thus our ability to develop novel therapeutics to overcome this issue. Here, we describe the development of a clinically relevant chemoresistant mantle cell lymphoma model using the JeKo-1 cell line. This was achieved through a stepwise treatment selection strategy using gradually increasing concentrations of CHOP. We show that resistant JeKo-1 cells display strong recovery and fast proliferation after treatment with an IC50 dose of CHOP. We also found that resistant JeKo-1 cells overexpress three oncogenes implicated in the development of mantle cell lymphoma—Cyclin D1, Mcl-1, and Bcl-2—compared to normal JeKo-1 cells. We anticipate that in vitro models such as this one will enable the discovery of new therapeutic strategies for overcoming chemoresistance and improve clinical outcomes in mantle cell lymphoma patients. Impact statement Mantle cell lymphoma remains one of the deadliest subtypes of non-Hodgkin’s lymphoma, in large part because patients become resistant to frontline chemotherapy. The development of strategies to treat advanced disease will be contingent upon testing in appropriate models. Most in vitro models of resistant mantle cell lymphoma are laboratory grade models that do not recapitulate the low level of chemoresistance typically observed in patients, limiting their utility. This study develops a clinically relevant in vitro model that can be used to establish the mechanisms of resistance and test new therapeutics intended to treat recurrent disease.

Primary Spinal Epidural Mantle Cell Lymphoma: Case Report

Neurosurgery ◽  
2000 ◽  
Vol 47 (5) ◽  
pp. 1239-1242 ◽  
Author(s):  
Maja Barnard ◽  
Bayardo Perez-Ordoñez ◽  
David W. Rowed ◽  
Lee Cyn Ang
Keyword(s):  
Mantle Cell Lymphoma ◽  
Hodgkin’S Lymphoma ◽  
Cell Lymphoma ◽  
Hodgkin's Lymphoma ◽  
Pathological Examination ◽  
Incomplete Resection ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell ◽  
Spinal Epidural

Abstract OBJECTIVE AND IMPORTANCE Mantle cell lymphoma is a distinct clinicopathological type of non-Hodgkin's lymphoma that often presents at an advanced stage, with systemic spread. Spinal involvement is uncommon and generally occurs as part of advanced disease or generalized relapses. Primary spinal epidural lymphoma is a rare initial manifestation of non-Hodgkin's lymphoma, and mantle cell lymphoma with initial presentation in the spinal epidural space is extremely rare, having been previously reported in only two cases. CLINICAL PRESENTATION We report a case of a 71-year-old man who presented with increasing weakness and numbness of the legs. Magnetic resonance imaging revealed a spinal epidural mass in the lumbosacral region. INTERVENTION The patient underwent a partial L4 and L5–S1 laminectomy, with incomplete resection of the mass for spinal decompression and tissue diagnosis. Mantle cell lymphoma was diagnosed in the pathological examination. CONCLUSION After radiotherapy, the disease recurred with a soft-tissue mass in the anterior maxillary area of the face. The patient underwent restaging and was treated with chemotherapy, with only a partial response. Mantle cell lymphoma with primary spinal epidural presentation is rare. This diagnosis can be established and other causes of spinal cord compression can be ruled out by obtaining tissue for proper histopathological examinations. Because of its aggressive behavior and poor prognosis, mantle cell lymphoma should be treated using a combined-modality approach.

Phase II Study of Rituximab Combined with Cladribine and Mitoxantrone in Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4946-4946
Author(s):  
Shuichi Ota ◽  
Junji Tanaka ◽  
Masanobu Nakata ◽  
Kiyotoshi Imai ◽  
Masahiro Ogasawara ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Median Time ◽  
Hodgkin’S Lymphoma ◽  
Cell Lymphoma ◽  
Hodgkin's Lymphoma ◽  
Severe Neutropenia ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell ◽  
Grade 3

Abstract BACKGROUND. Synergistic or additive activities for rituximab and cladribine have been shown in preclinical studies. Indolent Non-Hodgkin’s lymphoma (I-NHL) tends to recur with shortening intervals of remission after standard chemotherapy. New modalities of treatment are necessary. Therefore, we evaluated the feasibility, efficacy, and toxicity of combined regimen that consisted of rituximab plus cladribine plus mitoxantrone (the RCM regimen) in the treatment of patients with relapsed or refractory I-NHL. METHODS. The RCM protocol consisted of rituximab at a dose of 375 mg/m2 on Day 1, cladribine at a dose of 0.09 mg/kg per day on Days 2 through 6, and intravenous mitoxantrone at a dose of 6 mg or 10 mg/m2 per day on Day 2. The RCM courses were repeated at 4-week intervals, for up to 4 cycles. RESULTS. Fourteen patients with I-NHL and one patient with mantle cell lymphoma entered in the study. The median age was 60 (range 47–77) and 8 were females. Histology was small lymphocytic lymphoma (n=1), follicular lymphoma (n=13), mantle cell lymphoma (n=1). Median time from diagnosis to RCM treatment was 3.6 (range 0.2–8.1) years and median number of prior treatment regimen was 2 (range 1–4). Twelve patients (80%) had recurrent disease after prior therapy including high dose therapy with autologous stem cell transplant, and 3 patients (20%) had refractory disease. Thirteen patients were treated on the RCM regimen, and 8 patients (61.5%) achieved a complete response, 3 patients (23.1%) achieved a partial response. Therefore, the overall response rate was 92.3%. Median time to response was 2.8 months (range 1.0–6.7). Median progression free survival of responders was 16.5 (range 1.3–25.5) months. The treatment revealed tolerability, with episodes of severe neutropenia (grade 3 and 4) observed in 12 patients (85.7%), episodes of grade 3 and 4 thrombocytopenia observed in 2 patients (15.4%). However, severe infections were not observed in any patients. CONCLUSIONS. The RCM regimen is highly effective and well tolerated modalities of treatment in heavily pretreated and relapsed or refractory patients with I-NHL.

Safety analysis of radioimmunotherapy (RIT) in patients with relapsed or refractory low grade, follicular or transformed non-Hodgkin's lymphoma and mantle cell lymphoma based on age at time of therapy

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19529-e19529
Author(s):  
E. Braun ◽  
D. Katz ◽  
P. Venugopal ◽  
M. Larson ◽  
J. Shammo ◽  
...  
Keyword(s):  
Platelet Count ◽  
Mantle Cell Lymphoma ◽  
Hodgkin’S Lymphoma ◽  
Cell Lymphoma ◽  
Hodgkin's Lymphoma ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell ◽  
Group 2 ◽  
Group 1

e19529 Background: Radioimmunotherapy is a therapeutic option for relapsed or refractory indolent, follicular and transformed non Hodgkin's lymphoma and mantle cell lymphoma. Although prolongued myelotoxicity has been described with use of iodine I 131 tositumomab (TOSI) and yttrium 90 ibritumomab tiuxetan (IBRI), analysis of toxicity according to patients’ age at therapy still lacks. Methods: Utilizing the Rush University Medical Center database 61 subjects who received RIT between November/2003 and June/2008, either with TOSI or IBRI were divided in 2 groups according to age at time of therapy. Group 1 included patients between 33 and 60 (51.8±6.5) years of age (N=29) and group 2 included patients 61 years old or older (70.1±7.8) (N=32). Parameters compared between groups were: Time to nadir of lowest absolute neutrophil count (ANC), time to recovery ANC above 1000/mcL, time to nadir of lowest hemoglobin levels, time to recovery to hemoglobin levels above 8g/dL, time to lowest platelet count and time to recovery to platelet count above 100,000/mcL. Incidence o myelodysplastic syndrome (MDS) was also compared between groups. Groups characteristics such as sex, type of RIT, presence of disease in bone marrow, FLIPI/IPI and use of G-CSF were noted. Results: There was no significant statistical difference between groups in time (number of days) to achieve nadir of ANC (group 1 85.3±208; group 2 50.3±19.9), nadir of hemoglobin levels (group 1 106±60.6; group 2 84±57.0) and time to nadir of platelet level (group 1 53.5±70.7; group 2 41.8±9.6). There was no statistical significant difference between groups in duration of cytopenias, except for time for platelet recovery which was significant longer in group 2 using the Pearson Correlation analysis. (p=0.008). (Days for platelets recovery to levels above 100,000/mcL group 1 29.4±27.7; group 2 108.8 ±207.3). One patient in group 1 and three patients on group 2 were diagnosed with MDS but were also treated with different chemotherapy regimens. Conclusions: RIT should be considered a safe therapeutic modality in patients with refractory or relapsed indolent, follicular, NHL, transformed and Mantle Cell lymphoma regardless of age. [Table: see text]

R-CHOP, Followed by High Dose Therapy and Autologous Stem Cell Rescue (HDT/ASCR), and R-Hypercvad Have Equivalent Progression-Free Survival and Are Superior to R-CHOP Alone in Younger Patients with Mantle Cell Lymphoma: a Comparative Effectiveness Analysis From the National Comprehensive Cancer Network (NCCN) Non-Hodgkin's Lymphoma Outcomes Database Project.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 403-403 ◽  
Author(s):  
Ann LaCasce ◽  
Jonathan L. Vandergrift ◽  
Maria A. Rodriguez ◽  
Allison L. Crosby ◽  
Eva M. Lepisto ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Board Of Directors ◽  
Induction Therapy ◽  
Research Funding ◽  
Hodgkin’S Lymphoma ◽  
Cell Lymphoma ◽  
Hodgkin's Lymphoma ◽  
Advisory Committees ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell

Abstract Abstract 403 Background: Mantle Cell Lymphoma (MCL) is an uncommon histology of non-Hodgkin's lymphoma (NHL) with an unfavorable prognosis for which optimal initial therapy has not been clearly defined. Despite a number of single center studies and uncontrolled trials examining first-line therapy options in MCL, no randomized clinical trials or observational studies have directly compared initial therapeutic options in a single cohort of patients. The role of aggressive induction therapy versus sequential standard chemotherapy remains uncertain, particularly in younger patients. We therefore used the NCCN NHL Outcomes Database to compare R-HyperCVAD, R-CHOP followed by HDT/ASCR and R-CHOP alone as first-line therapy. Our endpoints were progression-free survival (PFS) and overall survival (OS). Methods: The NCCN Non-Hodgkin's Lymphoma Outcomes Database is a prospective cohort study collecting comprehensive clinical, treatment, and outcome data for patients seen at 7 participating NCCN centers. Overall, 229 patients <65 years old with newly diagnosed MCL presented at NCCN institutions between August 2000 and February 2009. Patients were excluded if they (1) were enrolled in clinical trial (n=27), (2) did not receive Rituximab therapy (n=27), (3) did not receive either R-HyperCVAD or R-CHOP induction therapy (n=10), or (4) received both R-CHOP and R-HyperCVAD as induction (n=9). Induction therapy was determined as the initial chemo-immunotherapy received within 180 days of diagnosis. HDT/ASCR consolidation was defined as a transplant after achieving remission. In the R-CHOP+ HDT/ASCR group, ASCR was initiated within 100 days of induction therapy for 90% of patients. The maximum time from induction to ASCR was 172 days. In total, 156 patients were included in the final analysis. Median follow-up was 30 months. Results: Overall, 28 (18%) patients received R-CHOP alone, 29 (19%) received R-CHOP+HDT/ASCR, and 99 (63%) received R-HyperCVAD. No significant differences were observed between therapy groups with regards to co-morbidity (p=0.419), ECOG performance status (p=0.216), B symptoms (p=0.685), bulky disease (p=0.647), IPI risk group (p=0.247), or bone marrow involvement (p=0.651). No difference in PFS (p=0.546) was observed between the R-HyperCVAD and R-CHOP+HDT/ASCR arm (figure 1a). R-CHOP without consolidation had significantly poorer PFS than both R-HyperCVAD (p=0.001) and R-CHOP+HDT/ASCR (p=0.001). No significant differences in OS were observed between the three groups. However, there was a strong trend favoring R-HyperCVAD over R-CHOP (p=0.082, figure 1b). Conclusion: R-CHOP was inferior to both R-HyperCVAD and R-CHOP+HDT/ASCR, which had equal PFS and OS in patients with de novo mantle cell lymphoma. Even with these aggressive induction regimens in younger patient populations, the median PFS in these cohorts was only 3 years. Future trials should focus on incorporating novel agents rather than comparing efficacy of current suboptimal regimens. Disclosures: Czuczman: NCCN: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Nademanee:Genzyme Corporation: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Blayney:American Society of Clinical Oncology: Membership on an entity's Board of Directors or advisory committees; BlueCross Blue Shield of Michigan: Research Funding; NCCN: Honoraria; University of Michigan Health System: Employment. Friedberg:Genentech: Membership on an entity's Board of Directors or advisory committees.

Phase II Study of Proteasome Inhibitor Bortezomib in Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

2005 ◽  
Vol 23 (4) ◽  
pp. 667-675 ◽  
Author(s):  
Andre Goy ◽  
Anas Younes ◽  
Peter McLaughlin ◽  
Barbara Pro ◽  
Jorge E. Romaguera ◽  
...  
Keyword(s):  
B Cell ◽  
Mantle Cell Lymphoma ◽  
Hodgkin’S Lymphoma ◽  
Cell Lymphoma ◽  
Hodgkin's Lymphoma ◽  
B Cell Lymphomas ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell ◽  
Large B Cell

Purpose Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Patients and Methods Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or arm B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib was administered as an intravenous push (1.5 mg/m2) on days 1, 4, 8, and 11 every 21 days for a maximum of six cycles. Results Sixty patients with a median number of prior therapies of 3.5 (range, one to 12 therapies) were enrolled; 33 patients were in arm A and 27 were in arm B, including 12 diffuse large B-cell lymphomas, five follicular lymphomas (FL), three transformed FLs, four small lymphocytic lymphomas (SLL), two Waldenström's macroglobulinemias (WM), and one marginal zone lymphoma. In arm A, 12 of 29 assessable patients responded (six complete responses [CR] and six partial responses [PR]) for an overall response rate (ORR) of 41% (95% CI, 24% to 61%), and a median time to progression not reached yet, with a median follow-up of 9.3 months (range, 1.7 to 24 months). In arm B, four of 21 assessable patients responded (one SLL patient had a CR, one FL patient had a CR unconfirmed, one diffuse large B-cell lymphoma patient had a PR, and one WM patient had a PR) for an ORR of 19% (95% CI, 5% to 42%). Grade 3 toxicity included thrombocytopenia (47%), gastrointestinal (20%), fatigue (13%), neutropenia (10%), and peripheral neuropathy (5%). Grade 4 toxicity occurred in nine patients (15%), and three deaths from progression of disease occurred within 30 days of withdrawal from study. Conclusion Bortezomib showed promising activity in relapsed mantle-cell lymphoma and encouraging results in other B-cell lymphomas. Future studies will explore bortezomib in combination with other cytotoxic or biologic agents.

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